A Multiple Ascending Dose Study of R1507 in Patients With Advanced Solid Tumors.
- Registration Number
- NCT00400361
- Lead Sponsor
- Hoffmann-La Roche
- Brief Summary
This study will determine the maximum tolerated dose and pharmacokinetic profile of R1507 in patients with metastatic or locally advanced malignant solid tumors, non-Hodgkin's lymphoma or Hodgkin's lymphoma. Groups of patients will be sequentially enrolled to receive ascending doses of R1507 either weekly or three-weekly by intravenous infusion. The starting dose of 1mg/kg iv for each dosing regimen will be escalated in subsequent groups of patients after a satisfactory assessment of safety, tolerability and pharmacokinetics of the previous dose. The anticipated time on study treatment is until disease progression or dose-limiting toxicity, and the target sample size is \<100 individuals.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 98
Inclusion Criteria
- adult patients, >=18 years of age;
- solid neoplasm, non-Hodgkin's lymphoma or Hodgkin's lymphoma;
- metastatic or locally advanced disease, not curable by any currently available treatment.
Exclusion Criteria
- severe, uncontrolled systemic disease;
- patients who require treatment with glucocorticoids or immunosuppressive treatment within last 6 months;
- patients with diabetes mellitus.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description 1 RG1507 -
- Primary Outcome Measures
Name Time Method AEs, laboratory parameters, Cmax, Tmax, AUC, clearance, Vdss elimination half life Throughout study
- Secondary Outcome Measures
Name Time Method Tumor response Event driven